Chronic Low-back PainNCT06227767
Investigation of the Effect of Different Intensity Stabilization Exercises on Core Muscles
A study testing spinal stabilization exercise in people with Chronic Low-back Pain, run by Hasan Kalyoncu University at 2 sites in Turkey (Türkiye).
Trial summary
Chronic low back pain, which individuals have difficulty coping with in the modern age and is one of the most common reasons for applying to health institutions, has important consequences for individuals and society. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- spinal stabilization exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 22 Apr 2024to 13 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic low back pain for at least 3 months.
- Not having participated in any physiotherapy or exercise program in the last month.
- Patients with informed consent
Who cannot join
- Malignancy
- Severe osteoporosis
- Arthritis
- Bone diseases
- Pregnancy
- Diabetics
- Lumbar or lower limb surgery
- Rheumatological and inflammatory problems.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Adıyaman training and research hospital
Adıyaman, 02000
Hasan Kalyoncu University
Gaziantep, Gaziantep, 27000
About this study
Official title: Investigation of the Effect of Different Intensity Stabilization Exercises on Core Muscle Stiffness and Pain in Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial
Chronic low back pain, which individuals have difficulty coping with in the modern age and is one of the most common reasons for applying to health institutions, has important consequences for individuals and society. Approximately 80% of individuals experience low back pain throughout their lives, and 10-20% become chronic. Low back pain causes varying degrees of restrictions in individuals' daily living activities, modification or reduction of movements due to pain. This situation causes the pain to continue and causes the functional level to decrease in individuals with low back pain. There are many approaches to the treatment of chronic low back pain, and among these, exercise treatments have been shown to be effective in reducing pain and improving functionality. Spinal stabilization exercises, which have an important place among current exercise approaches for chronic low back pain, ensure the formation of a neutral position in the spine by activating the core muscles consisting of multifidus, transversus abdominis, diaphragm and pelvic floor muscles. Perception of neutral position is provided and applied in daily living activities. In this way, pain is reduced and functionality increases by providing appropriate loading. What kind of changes occur in the core muscles due to the strengthening of the core muscles as a result of spinal stabilization exercises is an important question that needs to be clarified scientifically. It is possible to observe the mechanical changes occurring in the core muscles with shear wave elastography, which has been frequently used in clinical research and practice in recent years. However, in the detailed literature review, no scientific studies were found that evaluated what level of exercise intensity produces optimal changes in the muscle and the correlation of these changes with pain and functional improvement. In this study, where different intensities of exercise will be applied, the mechanical changes occurring in the core muscles before and after exercise will be evaluated with shear wave elastography and the aim is to evaluate the correlation of these changes with pain and pain
Read the detailed description
Patients with chronic low back pain who voluntarily participate in the study will be randomly divided into three groups. Physical and demographic information of the patients participating in the study will be collected. The number of patients who will participate in the study will be determined by the power analysis to be performed at the beginning of the study. Low back pain, disability index and pain sensitivity will be measured before treatment, after treatment and at the 12th week. Evaluation of core muscles with shear wave would be done at the beginning of treatment and at the 12th week. The exercise program will be implemented in the hospital under the supervision of a physiotherapist for 6 weeks, and the next 6 weeks will be followed as a home program. Participants in the first group will be included in the exercise program planned in detail below, 2 days a week, and those in the second group 4 days a week. Patients included in the third group will be followed with a home exercise program. The exercise program is planned to be 40 minutes and the first 5 minutes of the program will be warm-up and the last 5 minutes will be cool-down exercises.
In the first phase of the exercise program, patients will be placed in the hook position and contraction of the transversus abdominis muscle and multifidus muscle will be taught. Then, patients will be asked to perform exercises that enable the activation of other muscles of the body while maintaining the contraction of the transversus abdominis and multifidus muscles, and these exercises will be progressed from easy to difficult exercises. During exercise, the activation of the patients' spinal stabilizer muscles will be kept under constant control and necessary warnings will be made in this regard. Exercises will initially start with 8-10 repetitions and gradually increase to 20 repetitions. All exercises will be performed in 2 sets and there will be 30 seconds of rest between sets.
- Conditions
- Chronic Low-back Pain
- Being tested
- spinal stabilization exercise
- Keywords
- low back pain, core stability, ultrasonography, disability, elasticity
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal stabilization exerciseOther
The exercise program will be implemented in the hospital under the supervision of a physiotherapist for 6 weeks, and the next 6 weeks will be followed as a home program. The first group will be given an exercise program 2 days a week, the second group will be given an exercise program 4 days a week. The exercise program is planned to be 40 minutes and the first 5 minutes of the program will be warm-up and the last 5 minutes will be cool-down exercises.
| Study group | Role | What they receive |
|---|---|---|
| exercise group twice a week | Active comparator | Spinal stabilization exercises determined by the authors will be applied 2 days a week for 40 minutes. Receives: Other: spinal stabilization exercise |
| exercise group four times a week | Active comparator | Spinal stabilization exercises determined by the authors will be applied 4 days a week for 40 minutes. Receives: Other: spinal stabilization exercise |
| control group | No intervention | Patients will be followed with a home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of muscle elasticity with elastography
The mechanical properties of the transversus abdominis, one of the core muscles, will be evaluated by the shear wave elastography method.
Measured: before treatment and 12nd (end of treatment) week of treatment
Secondary outcomes (3)
visual analog scale
The patients' low back pain severity will be evaluated with a visual analog scale. Visual Analogue Scale: The left end of a 10 cm straight line represents no pain, and the right end represents unbearable pain. The patient will be asked to mark the pain that feels on the Visual Analog Scale ruler during the test, and then this value will be measured and recorded with the help of a ruler
Measured: before treatment, 6th week of treatment and 12nd (end of treatment) week of treatment
oswestry disability index
In the survey, 10 pain questions evaluate the severity of pain personally, care, lifting, walking, sitting, standing, sleep, sexual life, social life, travel and the degree of change in pain. Scoring is between 0-5 for each item and items that are not answered will be excluded from evaluation.
Measured: before treatment, 6th week of treatment and 12nd (end of treatment) week of treatment
evaluation of pain sensitivity
A pressure pain meter device (JTECH CommanderTM) will be used to evaluate pain sensitivity in patients with chronic low back pain. The measurement will be made at 3 points and the points will be 2.5 cm apart vertically on the right and left lumbar paraspinal muscles.
Measured: before treatment, 6th week of treatment and 12nd (end of treatment) week of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start22 Apr 2024
- Primary completion26 Feb 2025
- Study completion13 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups of exercise and a control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, abuzer akbaş, Hasan Kalyoncu University
- Investigators
- abuzer akbas, Principal investigator, hasan kalyoncu university faculty of health science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227767
- Sponsor's protocol ID
- HasanKU_akbasa_001
- Status last verified
- May 2024
- First submitted
- 18 Jan 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akbas E, Ozdemir M, Akbas A, Usgu S, Bulut HT. Investigation of the effect of different intensity stabilization exercises on core muscle stiffness and pain in chronic low back pain: a single-blind, randomized controlled trial. Rheumatol Int. 2025 Aug 19;45(9):201. doi: 10.1007/s00296-025-05964-7.
PubMed 40828397
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Different Intensity Stabilization Exercises on Core Muscle Stiffness and Pain in Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06227767
- Acronym / sponsor ID
- HasanKU_akbasa_001
- Conditions
- Chronic Low-back Pain
- Keywords
- low back pain, core stability, ultrasonography, disability, elasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic low back pain, which individuals have difficulty coping with in the modern age and is one of the most common reasons for applying to health institutions, has important consequences for individuals and society. Approximately 80% of individuals experience low back pain throughout their lives, and 10-20% become chronic. Low back pain causes varying degrees of restrictions in individuals' daily living activities, modification or reduction of movements due to pain. This situation causes the pain to continue and causes the functional level to decrease in individuals with low back pain. There are many approaches to the treatment of chronic low back pain, and among these, exercise treatments have been shown to be effective in reducing pain and improving functionality. Spinal stabilization exercises, which have an important place among current exercise approaches for chronic low back pain, ensure the formation of a neutral position in the spine by activating the core muscles consisting of multifidus, transversus abdominis, diaphragm and pelvic floor muscles. Perception of neutral position is provided and applied in daily living activities. In this way, pain is reduced and functionality increases by providing appropriate loading. What kind of changes occur in the core muscles due to the strengthening of the core muscles as a result of spinal stabilization exercises is an important question that needs to be clarified scientifically. It is possible to observe the mechanical changes occurring in the core muscles with shear wave elastography, which has been frequently used in clinical research and practice in recent years. However, in the detailed literature review, no scientific studies were found that evaluated what level of exercise intensity produces optimal changes in the muscle and the correlation of these changes with pain and functional improvement. In this study, where different intensities of exercise will be applied, the mechanical changes occurring in the core muscles before and after exercise will be evaluated with shear wave elastography and the aim is to evaluate the correlation of these changes with pain and pain
Detailed description
Patients with chronic low back pain who voluntarily participate in the study will be randomly divided into three groups. Physical and demographic information of the patients participating in the study will be collected. The number of patients who will participate in the study will be determined by the power analysis to be performed at the beginning of the study. Low back pain, disability index and pain sensitivity will be measured before treatment, after treatment and at the 12th week. Evaluation of core muscles with shear wave would be done at the beginning of treatment and at the 12th week. The exercise program will be implemented in the hospital under the supervision of a physiotherapist for 6 weeks, and the next 6 weeks will be followed as a home program. Participants in the first group will be included in the exercise program planned in detail below, 2 days a week, and those in the second group 4 days a week. Patients included in the third group will be followed with a home exercise program. The exercise program is planned to be 40 minutes and the first 5 minutes of the program will be warm-up and the last 5 minutes will be cool-down exercises.
In the first phase of the exercise program, patients will be placed in the hook position and contraction of the transversus abdominis muscle and multifidus muscle will be taught. Then, patients will be asked to perform exercises that enable the activation of other muscles of the body while maintaining the contraction of the transversus abdominis and multifidus muscles, and these exercises will be progressed from easy to difficult exercises. During exercise, the activation of the patients' spinal stabilizer muscles will be kept under constant control and necessary warnings will be made in this regard. Exercises will initially start with 8-10 repetitions and gradually increase to 20 repetitions. All exercises will be performed in 2 sets and there will be 30 seconds of rest between sets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- two groups of exercise and a control group
| Arm | Type | Receives |
|---|---|---|
| exercise group twice a week | Active comparator | Other: spinal stabilization exerciseSpinal stabilization exercises determined by the authors will be applied 2 days a week for 40 minutes. |
| exercise group four times a week | Active comparator | Other: spinal stabilization exerciseSpinal stabilization exercises determined by the authors will be applied 4 days a week for 40 minutes. |
| control group | No intervention | –Patients will be followed with a home exercise program |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Chronic low back pain for at least 3 months.
- Not having participated in any physiotherapy or exercise program in the last month.
- Patients with informed consent
Key exclusion criteria (8 listed)
- Malignancy
- Severe osteoporosis
- Arthritis
- Bone diseases
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal stabilization exerciseThe exercise program will be implemented in the hospital under the supervision of a physiotherapist for 6 weeks, and the next 6 weeks will be followed as a home program. The first group will be given an exercise program 2 days a week, the second group will be given an exercise program 4 days a week. The exercise program is planned to be 40 minutes and the first 5 minutes of the program will be warm-up and the last 5 minutes will be cool-down exercises. | Other | exercise group four times a week, exercise group twice a week |
Primary outcome
Evaluation of muscle elasticity with elastography
Time frame: before treatment and 12nd (end of treatment) week of treatment
The mechanical properties of the transversus abdominis, one of the core muscles, will be evaluated by the shear wave elastography method.
3 secondary outcomes
visual analog scale
Time frame: before treatment, 6th week of treatment and 12nd (end of treatment) week of treatment
oswestry disability index
Time frame: before treatment, 6th week of treatment and 12nd (end of treatment) week of treatment
evaluation of pain sensitivity
Time frame: before treatment, 6th week of treatment and 12nd (end of treatment) week of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Derived from this study: PubMed 40828397Akbas E, Ozdemir M, Akbas A, Usgu S, Bulut HT. Investigation of the effect of different intensity stabilization exercises on core muscle stiffness and pain in chronic low back pain: a single-blind, randomized controlled trial. Rheumatol Int. 2025 Aug 19;45(9):201. doi: 10.1007/s00296-025-05964-7.
- Individual participant dataSharing planned: No
Related trials for Chronic Low-back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
abuzer akbas principal investigator
hasan kalyoncu university faculty of health science
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal stabilization exercise in people with Chronic Low-back Pain, run by Hasan Kalyoncu University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of muscle elasticity with elastography (time frame: before treatment and 12nd (end of treatment) week of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06227767, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.